European Commission
Public Health

West Nile Virus and Blood Safety: Introduction to a Preparedness Plan in Europe

Commission Implementing Directive 2011/38/EU

of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life

Commission Directive 2009/135/EC

allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic.

Commission Directive 2005/61/EC

Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

Commission Directive 2005/62/EC

of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments.

Commission Directive 2004/33/EC

of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components.

Directive 2002/98/EC

of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

Communication from the Commission COM (2002) 479 final

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's Common Position regarding the proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending
Council Directive 2001/83/EC - (COM(2002) 479 final)

Common Position (EC) No 28/2002

Common Position (EC) No 28/2002 of 14 February 2002 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Official Journal C 113 E , 14/05/2002 P. 0093 - 0108:

Communication from the Commission COM (2001) 692 final

Amended proposal for a directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC

Opinion of the Economic and Social Committee (2002/C 48/16)

Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and the Council amending Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating stable derivatives of human blood or human plasma". Official Journal C 048 , 21/02/2002 P. 0069 - 0069:

Directive 2001/83/EC

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal L 311, 28/11/2001 P. 0067 - 0128

Proposal for a Directive COM/2001/0480 final

Proposal for a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating stable derivates of human blood or human plasma/* COM/2001/0480 final - COD 2001/0186 */. Official Journal C 304 E, 30/10/2001 P. 0334 - 0334:

European Parliament legislative resolution (COM(2000) 816)

European Parliament legislative resolution on the proposal for a European Parliament and Council directive setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC (COM(2000) 816 - C5-0034/2001 - 2000/0323(COD))

Opinion of the Economic and Social Committee (2001/C 221/18)

Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC". Official Journal C 221 , 07/08/2001 P. 0106 - 0109:

Proposal for a Directive of the European Parliament and of the Council COM (2000) 0816 final

Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC

Directive 2000/70/EC of the European Parliament and of the Council

Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma. Official Journal L 313 , 13/12/2000 P. 0022 - 0024:

COM(2011) - 2nd report on Voluntary and Unpaid Donation of Blood and Blood Components  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

Second Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Voluntary and Unpaid Donation of Blood and Blood Components

Communication from the Commission COM (2010) 03

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

Summary Table of Responses from Competent Authorities for Blood and Blood Components to the Questionnaire on the transposition and implementation of the European regulatory framework blood and blood components

Table of responses from member States' competent authorities for blood and blood components on the transposition and implementation of the Blood Directive

Table of responses from Member State’s Competent Authorities on blood and blood components to a questionnaire on the transposition of the Blood Directive

Report from the Commission to the Council and the European Parliament, the european economic and social Committee and the Committee of the regions- First report on the application of the Blood Directive

Report from the Commission to the Council and the European Parliament on the promotion by Member States of voluntary unpaid blood donations

Precautionary measures against WNV transmission by blood

Precautionary measures against vCJD transmission by blood

The impact of arthropod borne diseases (including WNV) on the safety of blood used for transfusion as well as organs used for transplantation in the European Community

Opinion of the Scientific Committee on Medicinal Products and Medical Devices

Opinion of the Scientific Committee on Medicinal Products and Medical Devices on:

"The impact of arthropod borne diseases (including WNV) on the safety of blood used for transfusion as well as organs used for transplantation in the European Community"

Council of Europe - Recommendation Rec (2003)11 of the Committee of Ministers to member states on:

The introduction of pathogen inactivation procedures for blood components

Council of Europe - Guide to the preparation, use and quality assurance of blood components - 9th edition (2003)

Council of Europe - Recommendation Rec(2002)11 of the Committee of Ministers to member states on:

The hospital's and clinician's role in the optimal use of blood and blood products

Europeanisation of Italian law 107/90 on the production of blood derivatives

Parliamentary questions - Written question P-0590/02

Council of Europe - Recommendation Rec(2001)4 on:

The prevention of the possible transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood transfusion

BSE: blood donations

Parliamentary questions - Written question E-0096/01

Council conclusions on organ donation and transplantation (2012/C 396/03)  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

Commission Implementing Directive 2012/25/EU  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

Commission Implementing Directive 2012/25/EU of 9 October 2012 laying down information procedures for the exchange, between Member States, of human organs intended for transplantation

Corrigendum to Directive 2010/45/EU

Corrigendum to Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010)

Directive 2010/45/EU of the European Parliament and of the Council

Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation

Communication from the Commission COM (2008) 819/3

Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States

Proposal for a Directive on standards of quality and safety of human organs intended for transplantation

Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States

Impact Assessment accompanying the Proposal for a Directive and the Action plan

Annexes

Resolution 2007/2210 on organ donation and transplantation: Policy actions at EU level

Conclusions No 15332/07 SAN 209 on Organ donation and transplantation

Citizen's summary on organ donation and transplantation

Organ Donation and Transplantation - Facts and Figures

Organ donation and transplantation: Policy options at EU level - Consultation documentat EU level - Consultation document Council of Europe Recommendation

Council of Europe Recommendation Rec(2004)7 of the Committee of Ministers to member states on organ trafficking

Commission Decision 2010/453/EU

Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council
Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments (translations available under "Tissues and cells - Other key documents")

Commission Directive 2006/86/EC

implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells

Commission Directive 2006/17/EC

implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells

Directive 2004/23/EC of the European Parliament and of the Council

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

Communication from the Commission COM (2004) 0080 final

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
/* COM/2004/0080 final - COD 2002/0128 */

European Parliament legislative resolution

on the Council common position adopting a European Parliament and Council directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (10133/3/2003 - C5-0416/2003 - 2002/0128(COD))

Communication from the Commission COM (2003) 0906 final

Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells /* SEC/2003/0906 final - COD 2002/0128 */

Common Position (EC) No 50/2003 of 22 July 2003

adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

Communication from the Commission COM (2003) 340 final

Amended Proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

Proposal for a Directive of the European Parliament and of the Council (COM(2002) 319 final

Opinion of the European Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells" (COM(2002) 319 final - 2002/0128 (COD)). Official Journal C 085 , 08/04/2003 P. 0044 - 0051

COM(2011) - 2nd Report on Voluntary and Unpaid Donation of Tissues and Cells  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

Second Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Voluntary and Unpaid Donation of Tissues and Cells

Communication from the Commission COM (2009) 708

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

Summary Table of Responses from Competent Authorities for Tissues and Cells: Questionnaire on the transposition and implementation of the European Tissues and Cells regulatory framework

(Year 2008)

Summary Table of Responses from Competent Authorities: Questionnaire on the transposition and implementation of the European Tissues and Cells regulatory framework

Summary Table of Responses from Competent Authorities: Questionnaire on the transposition and implementation of the European Tissues and Cells regulatory framework

Report on the promotion by Member States of voluntary unpaid donation of tissues and cells

Survey on measures taken by Member States to endeavour to ensure voluntary and unpaid donations of tissues and cells in compliance with article 12 of Directive 2004/23/EC

Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

The Operational Manual complements Commission Decision 2010/453/EU and aims to support EU Member States in implementing a series of regulatory tasks under Directives 2004/23/EC, 2006/17/EC and 2006/86/EC with respect to inspection of tissue and cell procurement and tissue establishments.

Comparative Analysis of Medically Assisted Reproduction in the EU: Regulation and Technologies

The study, conducted by the ESHRE, maps the existing practice of assisted reproductive technologies (ART). It provides an overview of existing legislation and reimbursement policies as well as established practices and cross-border aspects of ART.

The study was funded by the Commission. However, the findings of the study reflect the work undertaken by ESHRE, and do not necessarily represent the Commission's official position.

Report on the regulation of reproductive cell donation in the European Union

Opinion on the ethical aspects of umbilical cord blood banking - Opinion N° 19 -European Group on Ethics in Science and New Technologies  Deutsch (de) français (fr)

Council of Europe Guide to safety and quality assurance for organs, tissues and cells - 1st Edition (2002)

Commercial action for the storage of umbilical cord blood for obtaining stem cells

Parliamentary questions - Written question E-1079/01

Opinion on Ethical aspects of human tissue banking- Opinion N° 11 -European Group on Ethics in Science and New Technologies  Deutsch (de) français (fr)